JPS5832821A - Light screening packaged material containing photodegradable medicine - Google Patents
Light screening packaged material containing photodegradable medicineInfo
- Publication number
- JPS5832821A JPS5832821A JP13072081A JP13072081A JPS5832821A JP S5832821 A JPS5832821 A JP S5832821A JP 13072081 A JP13072081 A JP 13072081A JP 13072081 A JP13072081 A JP 13072081A JP S5832821 A JPS5832821 A JP S5832821A
- Authority
- JP
- Japan
- Prior art keywords
- light
- film
- medicine
- photodegradable
- light screening
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Landscapes
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
【発明の詳細な説明】
本発明は、遮光性包装物に関する。さらに詳しくは医薬
品の光分解を抑制するが、収納医薬１−
品を外部から透視できる遮光性包装物に関する。DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a light-shielding package. More specifically, the present invention relates to a light-shielding package that suppresses photodecomposition of medicines, but allows the stored medicines to be seen through from the outside.
光に感受性の高い医薬品について光分解を抑制するだめ
の工夫としては、光を完全匠遮光することが最も効果的
であることは云うまでもない。このためには、医薬品に
完全遮光包装をほどこすこと（例えばアルミパック包装
）が行われている。しかし、完全遮光包装は外部からの
透視が妨げられるから製剤の品質管理上好ましくな（、
商品価値の低下をきたす。本発明は。It goes without saying that the most effective way to suppress photodegradation of pharmaceuticals that are highly sensitive to light is to completely block out light. To this end, pharmaceuticals are packaged in completely light-shielding packaging (for example, aluminum pack packaging). However, completely light-shielding packaging is undesirable from the viewpoint of quality control of the preparation, as it prevents visibility from the outside.
This results in a decrease in product value. The present invention is.
光分解性医薬品に対して好適な遮光性包装物を提供する
ことを目的とする。かかる医薬品として特に重要なもの
は、ニフェジピン、ニカルジピン等ジヒドロピリジン系
化合物である。これらの医薬品には、光分解を受けやす
い難点がある。光分解は、波長４５０ ｎｍ以下の可視
及び紫外部領域で特に顕著であるが、さらに高波長の可
視部領域でも起る。また光エネルギーの強度が関係する
ことも明らかである。それ故、遮光包装に際しては可視
光線の透過を遮断するのが効果的であるが、一方内容物
透視の点からは少くとも波長６００ ｎｍにおいてｉ％
程度の光線を透過させる必要がある。このように光分解
性医薬品の遮光包装については相反する条件が要求され
る。The purpose of the present invention is to provide a light-shielding package suitable for photodegradable pharmaceuticals. Particularly important such pharmaceuticals are dihydropyridine compounds such as nifedipine and nicardipine. These drugs have the disadvantage of being susceptible to photodegradation. Photodegradation is particularly noticeable in the visible and ultraviolet regions below wavelengths of 450 nm, but also occurs in the visible region at even higher wavelengths. It is also clear that the intensity of light energy is relevant. Therefore, when using light-shielding packaging, it is effective to block the transmission of visible light, but on the other hand, from the perspective of seeing through the contents, i%
It is necessary to allow a certain amount of light to pass through. As described above, contradictory conditions are required for light-shielding packaging of photodegradable pharmaceuticals.
本発明者等は、このような事情のもとで鋭意研究を重ね
てきた゛が、遮光性フィルム“’ ＶＳ Ｓ １１０１
ＵＶ３ Ｂｒｏｗｎ ４−６７０°゛（塩化ビニル製、
厚さ２５０ｔｚｍ ：住友ベークライト株式会社製）の
使用顔料濃度の３〜５倍に相当する遮光性フィルムがジ
ヒドロピリジン系医薬品の光分解を防止するのに極めて
有効であることを知った。即ち本遮光性フィルムは後記
光透過性試験による測定から明らかなように波長５００
ｎｍ以下の光線を透過せず、波長６００ ｎｍ にお
いて’５ｆＬ ％程度、それ以上の波長で８０％程度ま
で透過する（第を図■〜■参照）。このようにこの遮光
性フィルムは６００ ｎｍ０
で徊・％程度、それ以下の波長の可視光線もかなり透過
するので、収納医薬品始光分解が起ることも予想された
が、予期に反して光分解は全くと云ってよい程起らず〔
後記（２）の試験結果参照〕しかも収納医薬品の透視が
可能であり１本発明の目的を達成し得た。本発明はこの
ような遮光性フィルムを使用する光分解性医薬品を１ヌ
納した遮光性包装物である。本発明の包装物としてはＦ
ＴＰ包装物やヒートシール包装物が挙げられ光性フィル
ムである。金属箔としてはアルミニウム箔等が用いられ
る。また遮光性フィルム３は、上記の如き光透過性を有
するものであり。The inventors of the present invention have conducted intensive research under these circumstances, and have developed a light-shielding film "'VS S 1101".
UV3 Brown 4-670°゛ (made of vinyl chloride,
It has been found that a light-shielding film having a thickness of 250 tzm (manufactured by Sumitomo Bakelite Co., Ltd.) with a pigment concentration 3 to 5 times that used is extremely effective in preventing photodecomposition of dihydropyridine drugs. That is, this light-shielding film has a wavelength of 500, as is clear from the light transmittance test described below.
It does not transmit light rays of wavelength 600 nm or less, and transmits approximately 5fL% at a wavelength of 600 nm, and up to approximately 80% at wavelengths longer than that (see Figures 1 to 2). In this way, this light-shielding film transmits visible light at a wavelength of 600 nm and below, so it was expected that photodegradation of stored medicines would occur, but contrary to expectations, photodegradation did not occur. It doesn't happen at all [
(See test results in (2) below) Furthermore, it was possible to see through the stored medicines, and one of the objects of the present invention could be achieved. The present invention is a light-shielding package containing one photodegradable drug using such a light-shielding film. The package of the present invention is F
Examples of photosensitive films include TP packaging and heat seal packaging. Aluminum foil or the like is used as the metal foil. Moreover, the light-shielding film 3 has the above-mentioned light transmittance.
通常ＦＴＰ包−〇場合厚さ２００〜３５０／Ａｍ程度の
塩化ビニールフィルムが用いられ、またヒートシール包
装の場合は厚さ８０μｍ程度のポリエチレンフィルムや
セロファンポリエチレンラミネートフィルム等が用いら
れる。これらのフィルム：′
リ −。Usually, in the case of FTP packaging, a vinyl chloride film with a thickness of about 200 to 350/Am is used, and in the case of heat seal packaging, a polyethylene film or cellophane polyethylene laminate film with a thickness of about 80 μm is used. These films:′
Lee.
は、防湿性を高め、・るため、塩化ビニ≠アンのような
防湿性フィルムを積層したものでもよ℃・。In order to increase moisture resistance, it is also possible to use a layer of moisture-proof film such as vinyl chloride.
なお、ヒートシール包装の場合２片面が金属箔−ｊ〜 であっても勿論差し支えない。In addition, in the case of heat seal packaging, two sides are metal foil -j~ Of course, there is no problem.
つぎに９本発明で使用する遮光性フィルムの光透過性試
験および本発明の包装物の安定性試験並びにその結果を
示す。Next, the light transmittance test of the light-shielding film used in the present invention and the stability test of the packaged product of the present invention and their results will be shown below.
（１）遮光性フィルムの光透過性試験
自記分光光度計（島津製作所製、島津ＵＶ−３００）の
セルホルダー（３）に第１図のように。(1) Light transmittance test of light-shielding film The cell holder (3) of a self-recording spectrophotometer (manufactured by Shimadzu Corporation, Shimadzu UV-300) was placed as shown in FIG.
光透過制御板（スリッ） ）Ｌｌ）および遮光性フィル
ム（λ）を取り付け、３００ｎｍから７００ ｎｍにわ
たってスキャンする。A light transmission control plate (slit) Ll) and a light-shielding film (λ) are attached, and scanning is performed from 300 nm to 700 nm.
住友ベークライト■製ＰＴＰフィルムｖＳＳ１１０１
ＵＶ３ ” Ｂｒｏｗｎ ４−６７０”■、該フィルム
の３倍濃度、４倍濃度、５倍濃度に相当する遮光性フィ
ルム■■■および住友ベークライト（ａ）製ＰＴＰフィ
ルム°’ ＶＳＳ １１０１ ＵＶ３ Ｒｅｄ］−３９
１”■の吸光特性を第２図π示す。なおいずれのフィル
ムも厚さ２５０μｍのものを使用した。PTP film made by Sumitomo Bakelite vSS1101
UV3 ”Brown 4-670”■, a light-shielding film corresponding to 3x, 4x, and 5x density of the film■■■ and PTP film manufactured by Sumitomo Bakelite (a) °' VSS 1101 UV3 Red]-39
The light absorption characteristics of 1"■ are shown in FIG.
（２） ニフェジピンの光安定性試験イ）ウェザ−メ
ーターによる試験
４−
試験方法：第呼図に示される曲線番号■■■および■で
示される吸収特性を示す遮光性フィルムを用いたニフェ
ジピン錠剤のＰＴＰ包装物にウェザ−メーター （東洋
理化工業製＋ ５ｔａｎｄａｒｄ ５ｕｎｓｈｉｎｅ
Ｗｅａｔｈｅｒ ＭｅｔｅｒＷＥ−８ＵＮ−ＨＣ型）で
５時間照射した。照射後二フェジピ／残存率をガスクロ
マトグラフィーで測定した。(2) Photostability test of nifedipine a) Weather meter test 4- Test method: Testing of nifedipine tablets using a light-shielding film exhibiting the absorption characteristics shown by curve numbers ■■■ and ■ shown in the reference diagram. Weather meter for PTP packaging (manufactured by Toyo Rika Kogyo + 5standard 5unshine)
Weather MeterWE-8UN-HC type) was used for irradiation for 5 hours. After irradiation, the difedipy/residual rate was measured by gas chromatography.
結果
検体（遮光性フィルム）残存率 備 考■
８７５％ Ｂｒｏｗｎ ４−６７
０ ＰＴＰ■ １００２％ Ｒｅ
ｄ １−３９１ ＰＴＴ’ （透視不可）■
９９０％ ■の３倍濃度■ ９
９．１％ ■の５倍濃度対照 ６９９
％ ＦＴＰ包装なし口）室内散乱光による試験
試験方法：第キ図に示される曲線番号■の吸収特性を示
す遮光性フィルムを用いたニフェジピン錠剤のＦＴＰ包
装物および対照と未
・ してニフェジピン錠剤寮包装物を、室内に自然保存
〔保存条件：室温、室内散乱光（蛍光灯下約５０ＯＬ×
）〕夫々の保存期間経過後のニフェジピン残存率を下表
に示す。Results Sample (light-shielding film) survival rate Notes ■
875% Brown 4-67
0 PTP ■ 1002% Re
d 1-391 PTT' (not transparent) ■
990% ■ 3 times the concentration ■ 9
9.1% ■5x concentration control 699
% (without FTP packaging) Test using indoor scattered light Test method: FTP packaging of nifedipine tablets using a light-shielding film exhibiting the absorption characteristics of curve number ■ shown in Figure K, and nifedipine tablets without and as a control. Naturally store the package indoors [Storage conditions: room temperature, indoor scattered light (approximately 50 OL under fluorescent light)
)] The nifedipine residual rate after each storage period is shown in the table below.
（３） ニカルジピンの光安定性試験試験方法：第十
図に示される曲線番号■でいたニカルジピフ錠剤のＦＴ
Ｐ包装に２世才同様に照射した。照射後の錠剤の外観変
化を色差計〔東京重色■製電子色差計ＭＯＤＥＬ ＴＣ
−５５Ｄ］で測定した。結果を照射前の検体との色差（
ΔＥ）で示す。(3) Photostability test of nicardipine Test method: FT of nicardipif tablets with curve number ■ shown in Figure 10
The P package was irradiated in the same way as the second generation. Changes in the appearance of tablets after irradiation are measured with a color difference meter [Electronic color difference meter MODEL TC manufactured by Tokyo Juishiki Co., Ltd.]
-55D]. The color difference between the results and the sample before irradiation (
ΔE).
結果：
検体（フィルムの種類） ΔＥ 肉眼的観察
備 考■ ０．１ わずかに
変色対照 ２３９ 非常に変色 通常
のポリ塩化ビニールResults: Specimen (film type) ΔE Macroscopic observation
Notes ■ 0.1 Slightly discolored Contrast 239 Very discolored Regular polyvinyl chloride
第１図は、光透過性試験の測定装置の状態図を示す。
（１）・・・・・・スリット、（２ｙ・・・・遮光性フ
ィルム。
（３）・・・・・・セルホルダー
第２図は、遮光性シートの吸光特性を示す。
■・・・・・・Ｂｒｏｗｎ ４−６７０フイルムの吸光
曲線■・・・・・■の３倍濃度に相当するシートの吸光
曲線■１１６００．〃 ４ 〃
〃■・・・・・・ ｔｔ！５ｔｔ
ｔｔ■・・・・・・Ｒｅｄ １−３９１フイル
ムの吸光曲線第３図は２本発明のＦＴＰ包装物の断面図
を示す。
４・・・・・・防湿性フィルム □
第４図は９本発明のヒートシール包装物の断面図を丞す
。
７−
１・・・・・・医薬品、２・・・・・遮光性フィルム（
または金属箔）３・・・・・・遮光性フィルム
特許出願人 住友ベークライト株式会社特許出願人 山
之内製薬株式会社
代理人 佐々木 晃 −
９−
８−
第１図
（Ａ）
（Ｂ） スリット野分
ｍｍFIG. 1 shows a state diagram of a measuring device for a light transmission test. (1)...Slit, (2y...Light-shielding film. (3)...Cell holder Figure 2 shows the light absorption characteristics of the light-shielding sheet. ■... ...Brown 4-670 film absorption curve ■...Extinction curve of sheet corresponding to three times the density of ■11600.〃 4 〃
〃■・・・・・・tt! 5tt
tt■....Extinction curve of Red 1-391 film FIG. 3 shows a cross-sectional view of two FTP packages of the present invention. 4 Moisture-proof film □ Figure 4 shows a cross-sectional view of the heat-sealed package of the present invention. 7- 1...Pharmaceuticals, 2...Light-shielding film (
or metal foil) 3...Light-shielding film patent applicant Sumitomo Bakelite Co., Ltd. Patent applicant Yamanouchi Pharmaceutical Co., Ltd. Agent Akira Sasaki - 9- 8- Figure 1 (A) (B) Slit Nowaki mm
Claims (1)
載の包装物。 （３） ヒートシール包装物である特許請娑１囲第（
１）項記載の包装物。 （４） 光分解性医薬品がニフェジピンまたは二カー
ジピ・である時許請晶囲第（１）項記載の包′装物。[Claims] A package containing a photodegradable drug using a plastic film. +2) The package according to claim 9 (1), which is an FTP package. (3) Part 1 of the Patent Application, which is a heat-sealed package (
Packages described in section 1). (4) When the photodegradable drug is nifedipine or dicadipine, the package according to claim 1 (1).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP13072081A JPS5832821A (en) | 1981-08-20 | 1981-08-20 | Light screening packaged material containing photodegradable medicine |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP13072081A JPS5832821A (en) | 1981-08-20 | 1981-08-20 | Light screening packaged material containing photodegradable medicine |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JPS5832821A true JPS5832821A (en) | 1983-02-25 |
Family
ID=15041010
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP13072081A Pending JPS5832821A (en) | 1981-08-20 | 1981-08-20 | Light screening packaged material containing photodegradable medicine |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPS5832821A (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2002539238A (en) * | 1999-03-20 | 2002-11-19 | エルティエス ローマン テラピー−ズュステーメ アーゲー | Method for improving the stability of a photosensitive treatment system or its components during storage and / or use |
| JP2005239692A (en) * | 2004-02-27 | 2005-09-08 | Rohto Pharmaceut Co Ltd | Medicinal composition containing tranilast housed in inclusion body |
| JP2017031103A (en) * | 2015-08-03 | 2017-02-09 | 大原薬品工業株式会社 | Pramipexole formulation packaging with improved light stability |
| JP2017039718A (en) * | 2015-08-18 | 2017-02-23 | 大原薬品工業株式会社 | Rosuvastatin calcium formulation packaging body in which light stability is improved |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5681390A (en) * | 1979-12-07 | 1981-07-03 | Chiyoda Chem Eng & Constr Co Ltd | Multistage hydrogenation treatment of coal |
-
1981
- 1981-08-20 JP JP13072081A patent/JPS5832821A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5681390A (en) * | 1979-12-07 | 1981-07-03 | Chiyoda Chem Eng & Constr Co Ltd | Multistage hydrogenation treatment of coal |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2002539238A (en) * | 1999-03-20 | 2002-11-19 | エルティエス ローマン テラピー−ズュステーメ アーゲー | Method for improving the stability of a photosensitive treatment system or its components during storage and / or use |
| JP2005239692A (en) * | 2004-02-27 | 2005-09-08 | Rohto Pharmaceut Co Ltd | Medicinal composition containing tranilast housed in inclusion body |
| JP2017031103A (en) * | 2015-08-03 | 2017-02-09 | 大原薬品工業株式会社 | Pramipexole formulation packaging with improved light stability |
| JP2017039718A (en) * | 2015-08-18 | 2017-02-23 | 大原薬品工業株式会社 | Rosuvastatin calcium formulation packaging body in which light stability is improved |
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